Denosumab vs Zoledronate After Vertebroplasty
Launched by SHENZHEN PEOPLE'S HOSPITAL · Oct 25, 2022
Trial Information
Current as of May 19, 2025
Completed
Keywords
ClinConnect Summary
Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Must be age between 50 and 90 years old
- • X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
- • Bone mineral density T value less than -1 via dual-energy X-ray
- • A recent fracture history less than 6 weeks
- • MRI show bone marrow edema of fractured vertebrae
- • low back pain, local paravertebral tenderness
- Exclusion Criteria:
- • Must be able to have no intervertebral fissure
- • Must be able to have no infection
- • Must be able to have no malignancy
- • Must be able to have no neurological dysfunction
- • Must be able to have no previous use of anti-osteoporosis drugs
- • Must be able to have no inability to perform magnetic resonance imaging
- • Must be able to have no prior back open surgery
- • Must be able to have no other established contraindications for elective surgery
About Shenzhen People's Hospital
Shenzhen People's Hospital is a leading medical institution in China, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to improving patient outcomes by exploring novel therapies and treatment modalities across various medical fields. With a state-of-the-art facility and a team of experienced healthcare professionals, Shenzhen People's Hospital fosters a collaborative environment for clinical research, ensuring adherence to rigorous ethical standards and regulatory requirements. Their focus on patient-centered care and commitment to scientific advancement positions them as a key player in the landscape of medical research in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shenzhen, Guangdong, China
Patients applied
Trial Officials
Xiao Xiao, Doctor
Principal Investigator
Shenzhen People's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials